Celltrion bringing original drug Zymfentra to U.S. market

The pharmaceutical giant received approval from the U.S. Food and Drug Administration for its treatment for inflammatory bowel disease.

Celltrion's Zymfentra, an autoimmune disease treatment approved by the U.S. Food and Drug Administration. [CELLTRION]

Celltrion is aiming for another big leap with the debut of Zymfentra, an autoimmune disease treatment, in the U.S. market.

It is the Korean company's first original drug to get approval from the U.S. Food and Drug Administration.

Celltrion said on Monday that Zymfentra, a subcutaneous injection formulation of its infliximab Remsima, was introduced in the U.S. market last week as a treatment for people living with ulcerative colitis or Crohn's disease.

The recommended dosage of Zymfentra is 120 milligrams every two weeks. The wholesale price of the drug has been set at approximately $6,181 for two doses based on a four-week course.

Celltrion founder and chairman Seo Jung-jin speaks about the company's merger plan at a press conference in western Seoul in October. [CELLTRION]

Celltrion aims to log revenues of 1 trillion won ($750 million) with Zymfentra by 2025 by reaching more than 10 percent of its target patients.

The launch is meaningful in that it is the first original drug developed by Celltrion, a company that has focused on biosimilars so far.

"With Zymfentra, Celltrion will accelerate to become a global biopharmaceutical company that does both new drug development and biosimilars," Celltrion founder and chairman Seo Jung-jin said during a press conference in October.

Celltrion is also in talks with various U.S. pharmacy benefit managers (PBMs) to get "preferred drug" status in the second quarter.

PBMs, third-party companies that function as intermediaries between insurance providers and pharmaceutical manufacturers, create lists of prescription medications covered by health insurance plans called formularies, negotiate rebates with manufacturers, process claims and occasionally manage mail-order specialty pharmacies.

The U.S. market for inflammatory bowel disease treatment, the target for Zymfentra, is valued at 12.8 trillion won, according to data from healthcare researcher IQVIA.

"Compared to Remsima SC in Europe, the net sales price is two or three times higher for Zymfentra, resulting in a very favorable cost ratio," said researcher Park Pyeong-kuk from NH Investment & Securities. "Considering the possibility of Zymfentra being listed by large U.S. PBMs in the second quarter, robust profit expansion is forecast starting from the fourth quarter."

Celltrion last year merged with Celltrion Healthcare three years after its original plan was announced. Celltrion Pharm will merge with Celltrion this year, according to Seo.

Celltrion aims to generate 12 trillion won in revenue by 2030, with around 5 trillion won coming from original drugs. The company currently has six biosimilar products, and aims to increase that number to 22 by 2030.

Celltrion shares closed at 182,500 won Monday, up 1 percent from the previous trading day.

BY SARAH CHEA [chea.sarah@joongang.co.kr]